Malpractice Case: Black Box Warnings Can Come Back to Bite in Court

Gordon T. Ownby


November 09, 2020

The patient experienced significant skin involvement on over half of her body, suffered ocular involvement, and required mechanical debridement and saline irrigation.

The patient sued Dr P, alleging that lamotrigine's "black box" warned of life-threatening rashes and that factors that may increase the risk for rash include "exceeding recommended initial dose of lamotrigine."

While Dr P could testify of past satisfactory experience with similar dose levels for other patients, the plaintiff would undoubtedly bring to trial an expert to describe why Dr P should have adopted a "start low and go slow" approach to avoid serious injury.

Significantly, Dr P's generic documentation of informed consent lacked any reference as to why he departed from the commonly understood recommendations for avoiding the low-frequency/high-risk rash associated with steep lamotrigine dosing. The patient and Dr P resolved the litigation informally.

Actual testimony from medical expert witnesses — not written guidelines or manufacturer warnings — still rules the day in medical malpractice litigation. But those guidelines and warnings will still come into evidence, and without a documented and detailed rationale for a physician's departure from those guidelines, defending such care will always be an uphill battle.

This case comes from the "Case of the Month" column featured in the member newsletter published by the Cooperative of American Physicians, Inc. The article was originally titled "The Black Box is Not the Standard of Care, but…"


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